A Phase 2 interventional study of CD5789 Cream 200 µg/g and CD5789 Cream 100 µg/g in Lamellar Ichthyosis, sponsored by Mayne Pharma International Pty Ltd. Terminated at 36 sites in 9 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Mayne Pharma International Pty Ltd · Phase 2, Interventional, and Treatment
This is a phase 2 randomized, multi-center, double-blind, vehicle controlled, 90 day, safety, efficacy, and systemic exposure study followed by a 90 day open-label extension of trifarotene cream in adults and adolescents with autosomal recessive ichthyosis with lamellar scale.
This is a 2-cohort, multicenter study in subjects with moderate to severe LI. Adults (Cohort A) and adults and adolescents (Cohort B) will be randomized in a double-blind fashion to 1 of 2 doses of active or vehicle and treated twice weekly for 90 days. Subjects who complete the randomized, double-blind portion of the study will be eligible to enter a 90 day, open-label extension study.
Approximately 15 adults (≥18 years old) will be randomized into the first cohort of subjects (Cohort A) in a 1:1:1 ratio and treated twice weekly for up to 90 days. If no safety issues are identified, both adults and adolescents (ages 12-17 years, inclusive) will be allowed to enroll in Cohort B. Subjects in Cohort B will be randomized 1:1:1 and treated twice weekly for up to 90 days in the same manner as subjects in Cohort A.
All subjects who complete 90 days of double-blind study treatment will be eligible to enroll in a 90 open-label extension. Subjects in the open-label extension will receive active twice weekly for up to 90 days.
7 studies on the registry are indexed under Ichthyosis, Lamellar; 1 is open to participants now.
Browse Ichthyosis, Lamellar studies →Mayne Pharma International Pty Ltd is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subject is not of , who is (absence of menstrual bleeding for 1 year before Baseline, without any other medical reason), or has documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy. For individuals with permanent infertility due to an alternate medical cause other than the above, (e.g., Mullerian agenesis, androgen insensitivity), investigator discretion should be applied to determining study entry.
OR
AND Male subjects may not donate sperm during the study and for at least 1 month after the last study drug application.
Note: Female subjects who are premenstrual at screening should nonetheless follow the pregnancy testing schedule for WOCBP even if they abstain from sexual intercourse while in the study and for at least 1 month after the last study drug application.
Exclusion criteria:
Subject with any of the following laboratory values at Screening:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD5789 200 µg/g, topical, 50g
Drug: CD5789 Cream 200 µg/g
CD5789 100 µg/g, topical, 50g
Drug: CD5789 Cream 100 µg/g
CD5789 Cream Vehicle, topical, 50g
Drug: CD5789 Cream Vehicle
Drug page: Trifarotene
A fixed dose (determined at Visit 1) of 200 µg/g applied topically twice weekly to up to 90% BSA
Drug page: Trifarotene
A fixed dose (determined at Visit 1) of 100 µg/g applied topically twice weekly to up to 90% BSA
A fixed dose (determined at Visit 1) applied topically twice weekly, up to 36 g per dose up to 90% BSA
The Percentage of Subjects in Each Treatment Group Who Experienced Successful Resolution of LI.
The percentage of subjects in each treatment group who experienced successful resolution of LI where "success" is defined as clear/almost clear on treated areas and at least a 2-grade change from Baseline at Day 90/end-of-treatment (EOT) in the Double-blind Period on the 5-point IGA full body scale.
Time frame: 90 Days
Total 16-point Visual Index for Ichthyosis Severity (VIIS)
5-point Visual Index for Ichthyosis Severity (VIIS) for scaling (overall 16 points) for scaling, i.e. 0-4 points for 4 body areas: chest/abdomen, back, arms and legs) where minimum is 0 and maximum is 16 (e.g. 4 points for each of the four body parts). 0 (Clear) No scaling 1. (Almost Clear) Very fine, non-coalescent scales 2. (Mild) Small and thin, non-coalescent scales 3. (Moderate) Large and rather thick scales starting to coalesce 4. (Severe) Very large, adherent, coalescent and very thick scales
Time frame: 90 Days
The Difference in Mean Scores Using Individual Score for Roughness
The amount of roughness of the skin will be measured on a 5-point scale. 0 (Clear) Smooth skin 1. (Almost Clear) Hardly palpably roughness 2. (Mild) Mild roughness (fine sand paper-like) 3. (Moderate) Moderate, coarse roughness (coarse sand paper-like) 4. (Severe) Very coarse skin (broken cornflakes-like)
Time frame: 90 Days
The Difference in Mean Scores Using Palm Sole Assessment
Thickening of the skin on the palms and soles will be measured on a 5-point scale: 0 (Clear) No thickening, no roughness, no fissure 1. (Almost Clear) Only slight thickening, minimal to no roughness, no fissures 2. (Mild) Some thickening, mild roughness on palpation, few fissures may be present 3. (Moderate) Substantial and diffuse thickening, coarse roughness on palpation may be present, fissures may be present 4. (Severe) Very thickened and rough skin, numerous fissures
Time frame: 90 Days
The Difference in Proportion of Subjects With Presence of Fissures on Palms Between the Active and Vehicle Groups
Fissuring will be assessed by recording the presence or absence of fissures, the number of fissures present, and the pain associated with each fissure. The subject will assess pain associated with fissures as ranging from 0-3 (none, mild, moderate, severe) at day 90 between the active trifarotene cream HE1 and vehicle groups
Time frame: 90 Days
Quality of Life Measurement Per Dermatology Life Quality Index (DLQI)
The DLQI, or the Dermatology Quality of Life Index, is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire with 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment); higher scores indicate poorer quality of life. Responses collected are on a scale of 0-3 depending on the question relevance to the subject. Response (Score) Very much (scored 3) A lot (scored 2) A little (scored 1) Not at all (scored 0) Not relevant (scored 0) A minimum score of 0 and maximum score of 30 is obtained by summing the score of each question. The higher the score, the more quality of life is impaired. 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life
Time frame: 90 Days
The Difference in Proportion of Subjects With Presence of Fissures on Soles Between the Active and Vehicle Groups
Fissuring will be assessed by recording the presence or absence of fissures, the number of fissures present, and the pain associated with each fissure. The subject will assess pain associated with fissures as ranging from 0-3 (none, mild, moderate, severe) at day 90 between the active trifarotene cream HE1 and vehicle groups
Time frame: 90 Days
The Difference in Mean Ectropion Scores Between the Active and Vehicle Groups
The Ectropion Severity Score (ESS), is a proven system to be reliable and sensitive to the presence of ectropion and has a maximum score of 8 points (0-8). A higher score indicates a worse ectropion. The score takes the severity of ectropion in terms of lateral and medial apposition, scleral show, conjunctival show, and roundness of the eye into account and gives an indication of the functional aspects involved in ectropion by scoring redness, excess tear film, and the position of the lacrimal punctum A point scale of 0=Nonaffected, 0.5=Emerging, 1= Affected is assigned to 8 observations. * Lateral apposition * Medial apposition * Sceral show * Conjunctival show * Excess team film * Redness of the eye * Round canthus * Punctum lacrimale
Time frame: 180 Days
Quality of Life Measurement Per EQ-5D-5L
The EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ visual analog scale (VAS). Descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 5 responses. 1. no problem 2. slight problems 3. moderate problems 4. severe problems 5. extreme problems It should be noted that the numerals 1-5 have no arithmetic properties and should not be used as a cardinal score. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 100-'the best health you can imagine' and 0-'the worst health you can imagine'. This information can be used as a quantitative measure of health as judged by the individual respondents.
Time frame: 180 Days
Incidents of Adverse Events
The number of subjects with AEs will be collected for each treatment group
Time frame: 180 Days
Measurement of Local Tolerability
Local tolerability will be assessed on a 0-3 scale (none, mild, moderate, severe).
Time frame: 180 Days
Clinical Laboratory Evaluations
The number of subjects with clinical laboratory values categorized as below (vital signs, 12 lead electrocardiogram, Physical Exam), within, or above normal ranges will be evaluated (changes from baseline for each clinical laboratory parameter by treatment group and by study visit).
Time frame: 180 Days
Measurement of Vital Signs
Blood pressure (systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\] and pulse will be measured. Measurement of actual values and changes from baseline will be calculated. Vital signs The number of subjects with vital signs values categorized as below, within, or above normal ranges (change from baseline for each parameter by period, by treatment group and by study visit).
Time frame: 180 Days
Measurement of 12-lead ECG Readings
The number of subjects with normal and abnormal ECG findings will be measured for each treatment group at each time point for QT and the QT interval corrected for heart rate (QTc) calculated using Fridericia's QT correction methods.
Time frame: 180 Days
Physical Examination Findings
The number of subjects with normal and abnormal findings in the complete physical examination for each treatment group. This is a limited physical examination to include HEENT, cardiorespiratory, abdomen, and range of motion.
Time frame: 180 Days
Measurement of Area Under the Plasma Concentration Versus Time Curve (AUC)
Measurement of the extent of absorption using estimates of the area-under-the-curve (AUC).
Time frame: 180 Days
Measurement of Peak Plasma Concentration (Cmax)
Measurement of therate-of-absorption using the maximum concentration (Cmax) and the time of Cmax (Tmax).
Time frame: 180 Days
| Milestone | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | CD5789 Cream Vehicle |
|---|---|---|---|
| Started | 23 | 21 | 21 |
| Completed | 14 | 18 | 17 |
| Not completed | 9 | 3 | 4 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 |
| Withdrew: Study discontinued by sponsor | 5 | 3 | 3 |
| Withdrew: Lack of efficacy | 2 | 0 | 1 |
| Milestone | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | CD5789 Cream Vehicle |
|---|---|---|---|
| Started | 49 | 0 | 0 |
| Completed | 39 | 0 | 0 |
| Not completed | 10 | 0 | 0 |
The percentage of subjects in each treatment group who experienced successful resolution of LI where "success" is defined as clear/almost clear on treated areas and at least a 2-grade change from Baseline at Day 90/end-of-treatment (EOT) in the Double-blind Period on the 5-point IGA full body scale.
| Participants | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | CD5789 Cream Vehicle |
|---|---|---|---|
| The Percentage of Subjects in Each Treatment Group Who Experienced Successful Resolution of LI. | 0 | 2 | 0 |
5-point Visual Index for Ichthyosis Severity (VIIS) for scaling (overall 16 points) for scaling, i.e. 0-4 points for 4 body areas: chest/abdomen, back, arms and legs) where minimum is 0 and maximum is 16 (e.g. 4 points for each of the four body parts). 0 (Clear) No scaling 1. (Almost Clear) Very fine, non-coalescent scales 2. (Mild) Small and thin, non-coalescent scales 3. (Moderate) Large and rather thick scales starting to coalesce 4. (Severe) Very large, adherent, coalescent and very thick scales
| units on a scale | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | Overall Trifarotene Cream (200 µg/g and 100 µg/g) | Vehicle Cream |
|---|---|---|---|---|
| Total 16-point Visual Index for Ichthyosis Severity (VIIS) | 10.9 ± 4.24 | 10.9 ± 3.51 | 10.9 ± 3.86 | 11.4 ± 2.94 |
The amount of roughness of the skin will be measured on a 5-point scale. 0 (Clear) Smooth skin 1. (Almost Clear) Hardly palpably roughness 2. (Mild) Mild roughness (fine sand paper-like) 3. (Moderate) Moderate, coarse roughness (coarse sand paper-like) 4. (Severe) Very coarse skin (broken cornflakes-like)
| score on a scale | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | Overall Trifarotene Cream (200 µg/g and 100 µg/g) | Vehicle Cream |
|---|---|---|---|---|
| The Difference in Mean Scores Using Individual Score for Roughness | 2.7 ± 1.10 | 2.7 ± 0.99 | 2.7 ± 1.02 | 3.1 ± 0.78 |
Thickening of the skin on the palms and soles will be measured on a 5-point scale: 0 (Clear) No thickening, no roughness, no fissure 1. (Almost Clear) Only slight thickening, minimal to no roughness, no fissures 2. (Mild) Some thickening, mild roughness on palpation, few fissures may be present 3. (Moderate) Substantial and diffuse thickening, coarse roughness on palpation may be present, fissures may be present 4. (Severe) Very thickened and rough skin, numerous fissures
| score on a scale | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | Overall Trifarotene Cream (200 µg/g and 100 µg/g) | Vehicle Cream |
|---|---|---|---|---|
| The Difference in Mean Scores Using Palm Sole Assessment | 2.1 ± 1.06 | 1.6 ± 1.27 | 1.9 ± 1.18 | 2.6 ± 1.06 |
Fissuring will be assessed by recording the presence or absence of fissures, the number of fissures present, and the pain associated with each fissure. The subject will assess pain associated with fissures as ranging from 0-3 (none, mild, moderate, severe) at day 90 between the active trifarotene cream HE1 and vehicle groups
| Participants | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | Overall Trifarotene Cream (200 µg/g and 100 µg/g) | Vehicle Cream |
|---|---|---|---|---|
| Number of participants with Fissures Present at Day 90 | 5 | 4 | 9 | 7 |
| Number of participants with no fissures present at day 90 | 10 | 12 | 22 | 10 |
The DLQI, or the Dermatology Quality of Life Index, is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire with 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment); higher scores indicate poorer quality of life. Responses collected are on a scale of 0-3 depending on the question relevance to the subject. Response (Score) Very much (scored 3) A lot (scored 2) A little (scored 1) Not at all (scored 0) Not relevant (scored 0) A minimum score of 0 and maximum score of 30 is obtained by summing the score of each question. The higher the score, the more quality of life is impaired. 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life
| score on a scale | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | Overall Trifarotene Cream (200 µg/g and 100 µg/g) | Vehicle Cream |
|---|---|---|---|---|
| Quality of Life Measurement Per Dermatology Life Quality Index (DLQI) | 6.1 ± 5.22 | 5.9 ± 5.21 | 6.0 ± 5.11 | 6.2 ± 5.78 |
Fissuring will be assessed by recording the presence or absence of fissures, the number of fissures present, and the pain associated with each fissure. The subject will assess pain associated with fissures as ranging from 0-3 (none, mild, moderate, severe) at day 90 between the active trifarotene cream HE1 and vehicle groups
| Participants | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | Overall Trifarotene Cream (200 µg/g and 100 µg/g) | Vehicle Cream |
|---|---|---|---|---|
| Numer of participants with fissures on soles present at day 90 | 5 | 4 | 9 | 7 |
| Numer of participants with no fissures on soles present at day 90 | 10 | 12 | 22 | 10 |
The Ectropion Severity Score (ESS), is a proven system to be reliable and sensitive to the presence of ectropion and has a maximum score of 8 points (0-8). A higher score indicates a worse ectropion. The score takes the severity of ectropion in terms of lateral and medial apposition, scleral show, conjunctival show, and roundness of the eye into account and gives an indication of the functional aspects involved in ectropion by scoring redness, excess tear film, and the position of the lacrimal punctum A point scale of 0=Nonaffected, 0.5=Emerging, 1= Affected is assigned to 8 observations. * Lateral apposition * Medial apposition * Sceral show * Conjunctival show * Excess team film * Redness of the eye * Round canthus * Punctum lacrimale
| score on a scale | CD5789 Cream 200 µg/g |
|---|---|
| The Difference in Mean Ectropion Scores Between the Active and Vehicle Groups | 2.82 ± 3.077 |
The EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ visual analog scale (VAS). Descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 5 responses. 1. no problem 2. slight problems 3. moderate problems 4. severe problems 5. extreme problems It should be noted that the numerals 1-5 have no arithmetic properties and should not be used as a cardinal score. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 100-'the best health you can imagine' and 0-'the worst health you can imagine'. This information can be used as a quantitative measure of health as judged by the individual respondents.
Results for this outcome have not been posted.
The number of subjects with AEs will be collected for each treatment group
Results for this outcome have not been posted.
Local tolerability will be assessed on a 0-3 scale (none, mild, moderate, severe).
Results for this outcome have not been posted.
The number of subjects with clinical laboratory values categorized as below (vital signs, 12 lead electrocardiogram, Physical Exam), within, or above normal ranges will be evaluated (changes from baseline for each clinical laboratory parameter by treatment group and by study visit).
Results for this outcome have not been posted.
Blood pressure (systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\] and pulse will be measured. Measurement of actual values and changes from baseline will be calculated. Vital signs The number of subjects with vital signs values categorized as below, within, or above normal ranges (change from baseline for each parameter by period, by treatment group and by study visit).
Results for this outcome have not been posted.
The number of subjects with normal and abnormal ECG findings will be measured for each treatment group at each time point for QT and the QT interval corrected for heart rate (QTc) calculated using Fridericia's QT correction methods.
Results for this outcome have not been posted.
The number of subjects with normal and abnormal findings in the complete physical examination for each treatment group. This is a limited physical examination to include HEENT, cardiorespiratory, abdomen, and range of motion.
Results for this outcome have not been posted.
Measurement of the extent of absorption using estimates of the area-under-the-curve (AUC).
Results for this outcome have not been posted.
Measurement of therate-of-absorption using the maximum concentration (Cmax) and the time of Cmax (Tmax).
Results for this outcome have not been posted.
Collected over The maximum study duration for each subject was approximately 291 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CD5789 Cream 200 µg/g | 0/23 (0%) | 0/23 (0%) | 10/23 (43.5%) |
| CD5789 Cream 100 µg/g | 0/21 (0%) | 0/21 (0%) | 7/21 (33.3%) |
| CD5789 Cream Vehicle | 0/21 (0%) | 0/21 (0%) | 11/21 (52.4%) |
| Event | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | CD5789 Cream Vehicle |
|---|---|---|---|
| DysmenorrhoeaReproductive system and breast disorders | 1/23 | 1/21 | 3/21 |
| HeadacheNervous system disorders | 3/23 | 1/21 | 2/21 |
| Back painMusculoskeletal and connective tissue disorders | 2/23 | 1/21 | 2/21 |
| NasopharyngitisInfections and infestations | 0/23 | 0/21 | 2/21 |
| Arthropod biteInjury, poisoning and procedural complications | 2/23 | 2/21 | 0/21 |
| PruritusSkin and subcutaneous tissue disorders | 2/23 | 0/21 | 0/21 |
| EczemaSkin and subcutaneous tissue disorders | 0/23 | 1/21 | 1/21 |
| DermatitisSkin and subcutaneous tissue disorders | 0/23 | 1/21 | 0/21 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 0/23 | 0/21 | 1/21 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/23 | 1/21 | 1/21 |
| Age, Categorical(Participants) | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | CD5789 Cream Vehicle | Total |
|---|---|---|---|---|
| <=18 years | 8 | 4 | 1 | 13 |
| Between 18 and 65 years | 15 | 14 | 19 | 48 |
| >=65 years | 0 | 3 | 1 | 4 |
| Age, Continuous(years) | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | CD5789 Cream Vehicle | Total |
|---|---|---|---|---|
| Mean | 32.1 ± 17.08 | 35.1 ± 20.70 | 31.5 ± 13.34 | 32.9 ± 17.09 |
| Sex: Female, Male(Participants) | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | CD5789 Cream Vehicle | Total |
|---|---|---|---|---|
| Female | 11 | 16 | 14 | 41 |
| Male | 12 | 5 | 7 | 24 |
| Ethnicity (NIH/OMB)(Participants) | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | CD5789 Cream Vehicle | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 0 | 2 |
| Not Hispanic or Latino | 23 | 17 | 20 | 60 |
| Unknown or Not Reported | 0 | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | CD5789 Cream Vehicle | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 3 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 | 8 |
| White | 18 | 15 | 13 | 46 |
| More than one race | 1 | 1 | 0 | 2 |
| Unknown or Not Reported | 1 | 3 | 1 | 5 |
| 5-point Investigator's Global Assessment [IGA](units on a scale) | CD5789 Cream 200 µg/g | CD5789 Cream 100 µg/g | CD5789 Cream Vehicle | Total |
|---|---|---|---|---|
| Mean | 3.5 ± 0.51 | 3.5 ± 0.51 | 3.3 ± 0.48 | 3.4 ± 0.50 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Trifarotene
Mayne Pharma International Pty Ltd